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NCT00296036 · ClinicalTrials.gov registry record · Phase 3
Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 137
- Enrollment target
NCT00296036: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00296036 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 137 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00296036, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 137 participants
- Enrollment target
Study Summary
RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream alone or a placebo in preventing hand-foot syndrome. PURPOSE: This randomized phase III trial is studying pyridoxine and topical urea/lactic acid-based cream to see how well they work compared with giving pyridoxine together with a placebo, giving topical urea/lactic acid-based cream together with a placebo, or giving two placebos in preventing hand-foot syndrome in patients who are receiving capecitabine for breast cancer or other cancer.
Primary Outcome
A patient self-reported hand-foot syndrome (HFSD), also known as palmar-plantar erythrodysesthesia, was completed daily while applying the cream. Patients rated skin severity symptoms individually in their hands and in their feet. Definitions of symptoms, which were based on Common Terminology Criteria for Adverse Events (CTCAE) v3.0, were provided to patients. The number of patients reporting moderate to severe symptoms in either hands or feet were tabulated and percentages are reported.
Interventions
- OTHER placebo
- DIETARY_SUPPLEMENT pyridoxine hydrochloride
- DRUG urea/lactic acid-based topical cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 137 participants |
| Start Date | 2006-06 |
| Phase | Phase 3 |
What the finished NCT00296036 record still lists
NCT00296036 is an interventional study that assigns participants to a tested intervention. The registered 137 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 3 interventions - of which placebo is the first listed.
NCT00296036 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00296036 about?
NCT00296036 is a clinical study titled "Pyridoxine and Topical Urea/Lactic Acid-Based Cream in Preventing Hand-Foot Syndrome in Patients Receiving Capecitabine for Breast Cancer or Other Cancer". RATIONALE: Pyridoxine (vitamin B6) and topical urea/lactic acid-based cream may prevent or lessen hand-foot syndrome caused by chemotherapy. It is not yet known whether giving pyridoxine with or without topical urea/lactic acid-based cream is more effective than topical urea/lactic acid-based cream ...
What is the current status of trial NCT00296036?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 137 participants. The study started on 2006-06.
What interventions are being tested in trial NCT00296036?
The interventions under investigation include: placebo (OTHER), pyridoxine hydrochloride (DIETARY_SUPPLEMENT), urea/lactic acid-based topical cream (DRUG).
Who is sponsoring clinical trial NCT00296036?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00296036's enrollment target sits among peer trials
137 1580th of 2000 higher than 421 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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